Takeaway: Although witness testimony about the level of skill in the art as of the filing date of the challenged patent is relevant, the witness need not have acquired that knowledge as of that date.

In its Final Written Decision, the Board found that Petitioner showed by a preponderance of the evidence that all challenged claims of the ’044 patent are unpatentable. The ’044 patent “relates to a method and apparatus for obtaining cells from multiple layers of epithelium by abrasion and without laceration,” disclosing in a preferred embodiment “a brush having bristles of sufficient stiffness to allow them to dislodge and sweep up cells from superficial, intermediate, and basal layers of epithelium, and to penetrate the basement membrane underlying the epithelium to reach the submucosa, without having to resort to the dangers of incisional-based biopsy.”

With regard to claim construction, the Board stated that no part of its Decision “relies on any specific construction of any claim term,” and therefore “no claim construction is necessary and the claims are accorded their broadest reasonable interpretation consistent with the specification.”

As a preliminary matter, the Board addressed a number of evidentiary issues applicable to both asserted grounds of unpatentability. First, Petitioner contended that a device disclosed in the Parasher Article (Ex. 1004) was “inherently capable of collecting a tissue sample as claimed.” The Board disagreed, finding that the Petition failed to identify “an explicit disclosure that the brush used for the experiments described in the Parasher Article was the Parasher brush.” Petitioner’s attorney argument was insufficient; therefore, the Board gave “no weight to the Parasher Article in [its] analysis.”

Second, the Board addressed Petitioner’s declaration of Dr. Michel Kahaleh. In particular, Petitioner cited to Dr. Kahaleh’s declaration in support of its argument that the Parasher brush “is capable of collecting a specimen that includes cells from tissue located below the surface of the epithelium.” The Board was not persuaded, citing to Dr. Kahaleh’s deposition testimony that contradicted Petitioner’s assertions.

With regard to Dr. Kahaleh’s qualifications, the Board disagreed with Patent Owner’s contention that Dr. Kahaleh was not qualified for not being a pathologist. In this regard, the Board was persuaded that Dr. Kahaleh had experience that was relevant to the field of the invention. Moreover, the Board disagreed with Patent Owner’s arguments that Dr. Kahaleh’s testimony should be given little weight because he did not have the relevant knowledge as of May 2001. The Board distinguished the Federal Circuit decision, Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962–63 (Fed. Cir. 1986), and PTAB decision, Schott Gemtron Corp. v. SSW Holding Co.Case IPR2013-00358, slip op. at 18 (PTAB Aug 20, 2014) (Paper 106), that were relied upon by Patent Owner. In particular, the Board found that “[a] witness must provide testimony about the level of skill in the art as of the critical date; however, the witness need not have acquired that knowledge as of the critical date.”

Turning to the prior art, the Board was persuaded that Petitioner showed by a preponderance of the evidence that Parasher anticipated challenged claims 1–8, 11–17, 23–28, 32, and 35–39. In particular, the Board disagreed with the implication of Patent Owner’s contentions that Parasher “must disclose such capability [of the claimed brush] in the words of the ’044 patent and with Patent Owner’s characterization of the reference.” Instead, “[t]he proper inquiry is what a person of ordinary skill in the art would understand as the capability of Parasher’s brush.” The Board was persuaded that Parasher disclosed a brush as claimed in the ’044 patent.

The Board next analyzed the parties’ reliance upon the testimony of Patent Owner’s expert Dr. Fromowitz. First, the Board found the testimony relied upon by Patent Owner not to be relevant to its consideration. However, the Board found that Dr. Fromowitz’s testimony instead supported “Petitioner’s contention that Parasher’s device dislodges cells from not only the surface, but also from within the epithelium,” which was also consistent with the Board’s analysis of the reference.

With respect to alleged obviousness of claims 9, 10, 29, and 20 over Parasher in view of Markus, the Board found that Patent Owner had not effectively challenged any material fact. In particular, Patent Owner relied upon its arguments regarding Parasher, which as discussed above, were rejected by the Board. Patent Owner also raised during oral hearing a new argument that the references could not be combined. The Board agreed with Petitioner’s objection, Paper 23, and did not consider the new argument.

In the end, the Board found all challenged claims to be unpatentable.

U.S. Endoscopy Group, Inc. v. CDX Diagnostics, Inc., IPR2014-00642

Paper 25: Final Written Decision

Dated: October 15, 2015

Patent: 6,258,044 B1

Before: Phillip J. Kauffman, Scott A. Daniels, and Barry L. Grossman

Written by: Daniels

Related Proceedings: CDx Diagnostics, Inc. v. U.S. Endoscopy Group, Inc., Case No. 1:13-cv-5669-NSR (S.D.N.Y.); IPR2014-00639 (challenging U.S. 6,676,609 B1, the “’609 patent”); IPR2014-00641 (challenging U.S. 7,004,913 B1, the “’913 patent”).